CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report
Comprehensive Reverse Shoulder Glenosphere Mini Baseplate recalled
Biomet is recalling Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper, distributed nationwide in the US. The recall was initiated on 25 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1615-2020
- FDA event ID
- 85143
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2020
- FDA classified
- 31 Mar 2020
- Reported
- 8 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2020 | Recall initiated by company | |
| 31 Mar 2020 | Classified by FDA | +35 days |
| 8 Apr 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
Where it was distributed
International distribution - country of Netherland.s
Questions about this recall
Is Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated recalled?
Yes. Biomet recalled Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated on 25 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1615-2020.
Why was it recalled?
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
Which lots are affected?
Lot Number: 410420 UDI: (01) 0 0880304 53246 5 (17) 290825 (10) 410420
Where was it sold?
International distribution - country of Netherland.s
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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